Breckenridge Pharmaceutical recalls
FDA enforcement reports naming Breckenridge Pharmaceutical, Inc as the recalling firm.
- Recall reports
- 35
- Class I (serious)
- 0
- Most recent report
- Jun 17, 2026
- Jun 17, 2026Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufact…Drug · Breckenridge Pharmaceutical, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitClass II
- Jun 17, 2026Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-7…Drug · Breckenridge Pharmaceutical, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitClass II
- May 13, 2026Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, MfrDrug · Breckenridge Pharmaceutical, Inc.CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitClass II
- Dec 10, 2025Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufac…Drug · Breckenridge Pharmaceutical, Inc.CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitClass II
- Dec 10, 2025Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufac…Drug · Breckenridge Pharmaceutical, Inc.CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limitClass II
- Nov 5, 2025Duloxetine Delayed-Release Capsules, USP, 60 mg, aDrug · Breckenridge Pharmaceutical, Inc.CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.Class II
- Sep 17, 2025Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Ma…Drug · Breckenridge Pharmaceutical, Inc.CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.Class II
- Aug 20, 2025Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Ma…Drug · Breckenridge Pharmaceutical, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.Class II
- Aug 13, 2025Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, MfrDrug · Breckenridge Pharmaceutical, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limitClass II
- Jul 16, 2025Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, MfrDrug · Breckenridge Pharmaceutical, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limitClass II
- Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactur…
- Duloxetine Delayed-Release Capsules USP, 30 mg, a
- Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Ma…
- Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr
- Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr
- Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-7…
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-74…
- Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr
- Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr
- Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 5199…
- Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr
- Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr
- Alprazolam Tablets, USP, 0
- Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharma…
- Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharma…
- Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01)…
- Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01…
- Alprazolam Tablets, USP, 0
- Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distribut…
- Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33)…
- Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33…
- Zoledronic Acid Injection 5 mg/100 mL (0
- Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed…
- Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactur…
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